Amgen Fresher Hiring
Location: Hyderabad, India
Experience Required: 0–6 Years
Qualification: B.Pharm, M.Pharm, BSc, MSc, or Life Sciences
Posted On: January 20, 2025
About the Role
Amgen, a global leader in biotechnology, is seeking a Sr. Associate – Regulatory Affairs to join their RA CMC (Regulatory Affairs, Chemistry, Manufacturing, and Controls) team. This role is integral to advancing product development and regulatory strategies to support Amgen’s mission of fighting serious illnesses through innovation. Amgen Fresher Hiring
Key Responsibilities
- Prepare and lead submissions for annual reports, facility registrations, renewals, and product updates.
- Collaborate with authors, reviewers, and subject matter experts to deliver high-quality CMC documents.
- Create submission content plans for various regulatory submissions.
- Coordinate and legalize country-specific CMC documents.
- Manage and archive CMC submissions in document management systems like Veeva Vault.
- Maintain CMC product timelines to align with project goals.
- Interface with regulatory operations teams to streamline workflows.
- Train team members on CMC procedures and document systems.
- Participate in cross-functional special projects to drive innovation.
Required Qualifications
Candidates must meet one of the following criteria:
- Master’s Degree (preferred).
- Bachelor’s Degree with 1–2 years of experience in manufacturing, QA/QC, or regulatory CMC within the pharmaceutical or biotechnology industry.
- Associate’s Degree with 6 years of relevant experience.
- High School Diploma/GED with 8 years of relevant experience.
Preferred Qualifications
- Bachelor’s Degree in Life Sciences.
- Experience in manufacturing, process development, quality assurance, or analytical development.
- Familiarity with regulatory CMC processes and industry standards.
- Strong project management and organizational skills.
- Proficiency in Veeva Vault or similar document management platforms.
- Excellent oral and written communication skills.
Why Join Amgen?
- Be part of a Fortune 500 company with a 40-year legacy in biotechnology.
- Work on challenging projects that improve lives worldwide.
- Enjoy a strong emphasis on work-life balance and career growth.
- Competitive insurance coverage and other benefits.
How to Apply
Interested candidates can explore this opportunity further by visiting Amgen Careers or directly applying through their official portal.
Note: This position provides an excellent platform for professionals passionate about advancing medical innovation and contributing to a world-class team. Amgen Fresher Hiring
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